Event Category: Pharma

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Paradigm Global Events is again proud to present our Orphan Drugs and Rare Diseases Global Congress 2020 Americas. It’s the 13th in the series of our Flagship tri-annual Orphan Drugs & Rare Diseases event. Due to the pandemic, we are looking to host a HYBRID Event, still the same congress but with a different set-up. This congress will provide you with a comprehensive overview of the critical issues shaping the future of Orphan Drugs.

The COVID-19 Pandemic has impacted the lives of just about everyone, patients receiving continuous treatment and care included. The Rare Disease community is already experiencing considerable challenges in achieving early and detailed diagnosis and having access to care and life-saving treatment, to chronic, highly complex, progressive and severely disabling nature of their diseases, which generate specific care needs. Undoubtedly, during this crisis, the rare diseases community is experiencing unprecedented overall disruption even more….

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Stem cell research, tissue engineering and regenerative medicine hold the potential to revolutionize the way human diseases are treated, and many nations have therefore invested heavily in these genetically engineered components and its applications. Considerable research has enabled the fabrication of sophisticated grafts and cell manipulation technologies to analyze the molecular level of controlling cell behavior and repairing tissue. However, these revolutionary medicines are also controversial with many ethical and regulatory questions that impact a nation’s policies.

The upcoming 2018 Stem Cell and Regenerative Medicine Congress focus on opportunities for innovation in the design and execution of clinical trials. Gain insights on:

• Trends in stem cell based disease modelling and drug discovery
• Challenges, solutions and progress on cell manufacturing and standardization
• Clinical and regulatory landscape of regenerative products
• Commercializing stem cell therapy and regenerative medicine and importance of collaboration
• Ethical, legal and social issues in regenerative medicine

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Paradigm Global Events is again proud to present its bi-annual Orphan Drugs & Rare Diseases Global Congress 2018 Europe. The conference will provide a unique platform for the convergence of stakeholders in the orphan drugs industry to discuss and network with top tier government, hospitals, pharmaceuticals, biopharmaceuticals, non-profit organisations, orphan drugs developers as well as regional and local manufacturers. We are putting together an agenda that address the driving macroeconomic factors, policies and issues that will steer the development of orphan drugs globally including commercialisation, policies, reimbursement, pricing and more. We look forward to having you be part of the event!

More information coming soon!

The pharmaceutical industry is one of the major players in the healthcare sector. Governments across Europe are struggling to balance the desire to provide timely access to innovative medicines with the need to contain healthcare spending due to the increasing pressure between the demands of the EU, national governments and regional authorities.

As healthcare budgets are continuously rising in Europe, governments implement a wide variety of policies to control them with the help of different public regulatory bodies that are involved in pharmaceutical coverage decisions across Europe.

At a global scale, pharmaceutical market was worth around $300 billion in 2015, according to World Health Organization, and it is expected to surpass $400 billion by 2018.

International collaboration among HTA and regulatory bodies can promote knowledge exchange, efficiency of information production and prepare developing systems for new challenges.

The upcoming 2017 Market Access, Pricing and Reimbursement Global Congress Europe will present a dynamic approach to key trends and insights on market access, health technology assessment, real world data, patient access, pricing and reimbursement on the current European landscape.

Biosimilars is a type of biological product that is similar to another drug, which has already been approved by the US FDA or European Medicines Agency. Due to their high degree of similarity with the biological reference product, they have no clinically evidenced and meaningful differences from the reference product in terms of quality, safety or efficacy.

The increasing pressure to decrease healthcare expenditures, growing demand due to its cost-effectiveness, expanding occurrence of different diseases, increasing numbers of biologics losing their market exclusivity, positive outcomes in ongoing clinical trials and rising demand in various therapeutic applications are all contributing factors for growth of the biosimilars market. Between 2015 and the end of 2019, 39 biologics with combined US sales of $41 billion, representing 30% of the total market will lose their marketing exclusivity. This resulted in huge interest by big pharma and biotech company venturing into the Biosimilar sector in order to gain a slice of multibillion worth of biologics market. Other factors increasing the demand for biosimilar drugs include rising disease incidences across the globe and better access to healthcare for all nations.

However, circumstance such as high manufacturing complexities and costs, rigorous regulatory requirements in countries, and innovative strategies by biologic drug manufacturers to restrict the entry of new players are restraining the growth of this market.

In this congress, we will cover a diverse range of topic and address the challenges and obstacle encountered by the industry from development to successful market of biosimilars. This will also offer and provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more.

The global orphan drugs market is expected to grow at a steady CAGR of 11.43% from 2016 to 2022. At the current forecasted growth rate, the orphan drugs market is expected to grow from USD 111.87 billion in 2016 and become worth USD 214.14 billion by 2022.

The growth of the global orphan drugs market is increasing due to the growing rare diseases. Orphan diseases are rare in nature which means its occurrence rate is very low, but its prevalence rate is expected to increase in the forecasted period thereby increasing the demand of global orphan diseases market. There are around 7000 rare types of rare diseases and disorders, these numbers are increasing day by day. 80% of rare diseases are genetically originated and rest are result of infections, environmental causes and allergies. Around 50% of genetic diseases are in children’s, 30 % of children with rare diseases cannot live for more than 5 years. Rare diseases are one of the life-threatening diseases that kills millions of lives worldwide. Orphan drugs are the pharmaceutical agent that is specially developed for rare diseases. The prevalence rate of rare diseases are growing at a faster rate, the result in growing need of drugs to cure that diseases.

Paradigm Global Events is again proud to present our bi-annual Orphan Drugs & Rare Diseases Global Congress 2017 Americas. The conference will provide a unique platform for the convergence of stakeholders in the orphan drugs industry to discuss and network with top tier government, hospitals, pharmaceuticals, biopharmaceuticals, non-profit organisations, orphan drugs developers as well as regional and local manufacturers. We are putting together an agenda that address the driving macroeconomic factors, policies and issues that will steer the development of orphan drugs globally including commercialisation, policies, reimbursement, pricing, access and more. We look forward to having you be part of the event!

The two-day Congress will provide an interactive and intimate discussion and networking format led by key industry speakers with intimate knowledge in the industry. Gain practical strategies and best practices on challenges, innovations, technologies and concepts surrounding orphan drugs and rare diseases.

In the competitive world of pharmaceutical and medical technology, market access represents the process of understanding the implications and the impact of a product in the healthcare market where a positive environment and communicating the ‘value’ of your product to the range of customers who influence uptake will make a big difference.

Only a fully integrated organisation can implement the processes, techniques and strategy required to get the right messages to the right stakeholders at the right time.

The U.S. pharma market is the largest pharmaceutical market worldwide, and continues to grow even though there are expected some structural changes in healthcare system due to evolving political landscape.
IMS Health has predicted that global spending will increase by 30% from 2015 to 2020, to US $1.4 trillion due in part to cheaper drugs, improved access and breakthrough innovations.

The two-days Market Access, Pricing and Reimbursement Global Congress 2017 Americas will provide a unique platform and a dynamic approach to key trends, methodologies and insights on market access, real world data, pricing, reimbursement, patient access and data collection than the current industry standard is anticipated.

Over the past decade, biomanufacturing has become a strategic driver to scalable and flexible operations, controlled costs, and high quality drug market access.¹  The advances in manufacturing technologies–in particular continuous manufacturing, process analytical technology, single-use systems, alternative down processing techniques and drug device systems–continue to influence the biopharmaceutical workforce, impacting the manufacturers’ collaboration strategies and their choices of facility locations.

In the upcoming BIOMANUFACTURING GLOBAL CONGRESS 2017 EUROPE, a more reactive and dynamic approach to key trends, methodologies and insights on manufacturing, supply chain, quality management and compliance than the current industry standard is anticipated.

Biosimilars & Follow-On Biologics 2017 Americas will cover a diverse range of topic and address the challenges and obstacle encountered by the industry from development to successful market of biosimilars. It will also offer and provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more.

Paradigm Global Events is again proud to present it’s bi-annual Orphan Drugs & Rare Diseases Global Congress 2017 Europe. The conference will provide a unique platform for the convergence of stakeholders in the orphan drugs industry to discuss and network with top tier government, hospitals, pharmaceuticals, biopharmaceuticals, non-profit organisations, orphan drugs developers as well as regional and local manufacturers. We are putting together an agenda that address the driving macroeconomic factors, policies and issues that will steer the development of orphan drugs globally including commercialisation, policies, reimbursement, pricing and more.

The global pharmaceutical industry is currently experiencing dynamic changes. Due to the high pressure of containing fixed costs all drug companies are reducing their internal capacities in R&D, marketing, manufacturing etc. in order to increase their outsourcing. Pharmaceutical companies big or small rely mainly on outsourcing service providers now more than ever to help solve problems, fulfil their tasks and improve efficiency and productivity. Thus it is crucial to create partnership opportunities to serve their individual needs.

The two-day Pharma Outsourcing & Partnership Global Congress 2017 Europe will provide a unique platform for the convergence of stakeholders in the industry to interact, discuss and network with top tier government, hospitals, pharmaceuticals, biopharmaceuticals and non-profit organizations as well as regional and local service providers to discuss and share on the outsourcing and partnership strategies, challenges and opportunities, global collaboration and the future of pharma outsourcing and partnership.

More information coming soon

Biosimilars is a type of biological product that is similar to another drug, which has already been approved by the US FDA or European Medicines Agency. Due to their high degree of similarity with the biological reference product, they have no clinically evidenced and meaningful differences from the reference product in terms of quality, safety or efficacy.

The increasing pressure to decrease healthcare expenditures, growing demand due to its cost-effectiveness, expanding occurrence of different diseases, increasing numbers of biologics losing their market exclusivity, positive outcomes in ongoing clinical trials and rising demand in various therapeutic applications are all contributing factors for growth of the biosimilars market. Between 2015 and the end of 2019, 39 biologics with combined US sales of $41 billion, representing 30% of the total market will lose their marketing exclusivity. This resulted in huge interest by big pharma and biotech company venturing into the Biosimilar sector in order to gain a slice of multibillion worth of biologics market. Other factors increasing the demand for biosimilar drugs include rising disease incidences across the globe and better access to healthcare for all nations.

However, circumstance such as high manufacturing complexities and costs, rigorous regulatory requirements in countries, and innovative strategies by biologic drug manufacturers to restrict the entry of new players are restraining the growth of this market.

In this congress, we will cover a diverse range of topic and address the challenges and obstacle encountered by the industry from development to successful market of biosimilars. This will also offer and provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more.

Gain Latest Insights on;

• Learn the current global regulatory guidelines and considerations for developing and bringing the next generation of Biosimilars to the market
• Know the strategies in place in developing and manufacturing biosimilars in emerging markets
• Establishing and integration of biosimilarity and comparability into developing Biosimilars
• Identify challenges encountered with Extrapolations and interchangeability, assessing immunogenicity and Pharmacovigilance
• Explore CMC regulatory challenges and considerations for Biosimilars drug development and manufacturing
• Study the pre-clinical and clinical challenges associated with the development of biosimilars
• The importance of establishing partnerships and successful collaboration for Biosimilars business
• Learn the latest updates, trends and current Biosimilars market situations in different regions
• What does the future hold for Biosimilars and Biologics
• Network with experts and leading drug developers, regulators and investors in the industry

Over the past decade, biomanufacturing has become a strategic driver to scalable and flexible operations, controlled costs, and high quality drug market access. The advances in manufacturing technologies–in particular continuous manufacturing, process analytical technology, single-use systems, alternative downprocessing techniques and drug device systems–continue to influence the biopharmaceutical workforce, impacting the manufacturers’ collaboration strategies and their choices of facility locations.

In the upcoming BIOMANUFACTURING GLOBAL CONGRESS 2016 EUROPE, a more reactive and dynamic approach to key trends, methodologies and insights on manufacturing, supply chain, quality management and compliance than the current industry standard is anticipated.

Gain latest insights on:

• Critical trends driving biomanufacturing production strategies
• Capacity-enhancing approaches ranging from technology solutions to business strategies
• Updates on emerging technologies and methods to cut costs and improve production efficiency
• Overarching industry pressures that are driving capacity needs and subsequent regulatory compliance
• Benchmarking manufacturing performance through metrics
• Mitigating supply chain risk through improved confidence

WHO WILL YOU MEET

Network with senior VPs, Heads, Directors, Managers and decision makers of leading biopharmaceutical and biotech companies whose responsibilities include Manufacturing, Process Development, Bioprocessing, Cell Cuture Manufacturing, Technical Operations, Process Excellence, Quality, Validation, Outsourcing and Regulatory.

Globally, the orphan drugs market “is forecast to reach US$148.9 billion by 2020, driven by the rising incidence of rare medical conditions, growing global population, and increasing focus of big pharmaceutical companies on orphan drug development.” (Orphan Drugs – A Global Strategic Business Report).

The industry is continuing to develop orphan drugs because developers invest less to put the drugs through clinical trials and marketed at higher prices when launched. Developers also receive incentives in terms of market exclusivity, reduced R&D costs and regulatory.

Orphan Drugs & Rare Diseases Global Congress 2016 Americas will provide a unique platform for the convergence of stakeholders in the orphan drugs industry to discuss and network with top tier government, hospitals, pharmaceuticals, biopharmaceuticals, nonprofit organizations, orphan drugs developers as well as regional and local manufacturers. We are putting together an agenda that address the driving macroeconomic factors, policies and issues that will steer the development of orphan drugs globally including commercialization, policies, reimbursement, pricing and more. We look forward to having you be part of the event!

Market access is a complex and protracted process that pharmaceutical and biotech companies go through in order to ensure their products are made available in as many countries as possible and most importantly that these products are reimbursed and made available to patients who needs them. Due to the development of more and more hi-tech drugs coming to the market, market access has become very important over the last 5-10 years resulting in increasing pressure on healthcare systems and/or governments to cut the costs of their drugs bills. For example, the National Institute of Clinical Excellence (NICE) plays a key role in the UK market – deciding whether or not new treatments are cost effective. In order for companies to have their products reimbursed at the best price possible by the NHS they must work harder, gather more data around the health economic impact and cost effectiveness of their products and present their data to NICE.

Today market access has become far more challenging due to a number of factors: the increase of competing drugs in the same therapeutic area, the need to contain rising costs, dependence of evidence based medicine and health technology assessment to influence payer decision. In addition, Biosimilar drugs have given payers more choice in deciding what products they will cover.

It has been said that the emerging markets are a key driver of the global pharmaceutical industry’s growth and will be for years to come. IMS Health has predicted that by 2017 they’ll account for one-third of industry sales and still be growing at double-digit rates.

The two-day Market Access, Pricing and Reimbursement 2016 Europe will provide a unique platform for the convergence of stakeholders in the industry to interact, discuss and network with top tier government, hospitals, pharmaceuticals, biopharmaceuticals and non-profit organizations as well as regional and local manufacturers to discuss and share on the macroeconomic factors, policies, issues and drivers that will steer pharmaceutical industry.